Other ocular surgery technologies include studies on iris reconstruction, viscoelastics, surgical instrumentation and intraoperative and postoperative drug therapy.
Iris reconstruction lens for the treatment of visual disturbances resulting from partial or total absence of the human iris
Do You Qualify?
Aniridia, which literally means “without iris,” is an eye condition characterized by the absence or partial absence of the iris muscle tissue. The iris, which is a disk of muscle suspended behind the cornea and immediately in front of the lens, regulates the amount of light entering the eye by adjusting the size of the pupil. The pupil is the hole in the middle of the iris that changes in size depending upon whether the iris contracts or relaxes. When there is a lot of light, the pupil becomes smaller and when there is a minimal amount of light, the pupil becomes larger. Because of the damage to the iris tissue in patients with aniridia, a greater than normal amount of light enters the eye, which results in visual impairment.
Individuals with aniridia may experience symptoms such as decreased vision, photo-sensitivity (light sensitivity), glare and optical aberrations such as halos and starbursts. The degree to which an individual might experience symptoms can range from mild, such as experiencing disturbances under particular lighting conditions, to severe, such as non-functioning vision.
If you experience aniridia, you should speak with your eye doctor to discuss treatment options and continuing care. The Study for Patients with Traumatic or Congenital Aniridia may be an appropriate option for you.
For more information about this study, please contact us and we will be happy to talk with you in more detail to determine if you qualify.
The purpose of this study is to evaluate the safety and efficacy of an investigational Iris Reconstruction Implant (artificial iris or iris IOL combination) in patients with congenital or traumatic iris loss.
Summary of the Procedure
The Iris Reconstruction Implant, produced and distributed by OPHTEC BV, is an investigational artificial iris available in blue, brown or green. (Figure 1) The Iris Reconstruction Implant is made from material similar to that used for lenses implanted after cataract surgery and is intended to remain in the eye permanently. More information on the Iris Reconstruction Implant can be found at www.ophtec.com.
With the eye under topical or local anesthetic, an incision is made in the clear or white part of the eye. The surgeon then inserts the Iris Reconstruction Implant and may also suture it into place. Following implantation, the implant rests behind the existing iris tissue.
Brief Eligibility Checklist
- Candidate for iris reconstruction surgery.
- Patients with clinically significant and measurable visual disturbances, such as glare, halos, photophobia, and starbursts.
- Patients undergo a standard surgical evaluation.
- Surgery is completed at our Minneapolis location.
- Postoperative evaluations are required at specific intervals following the surgery over a three-year period.
Contact - firstname.lastname@example.org or call (612) 813-3607
Study History- Other Surgery Technology
Randomized, double-masked, comparison of the aqueous humor concentration of loteprednol etabonate following administration of loteprednol etabonate and tobramycin versus loteprednol etabonate during routine cataract surgery
Randomized, double-masked, parallel-group study evaluating the safety and analgesic efficacy of ketorolac tromethamine 0.4% ophthalmic solution in post-photorefractive keratectomy patients
Compassionate use of the artificial iris devices for iris reconstruction in patients with traumatic aniridia
Topical steroid use versus no steroid use following LASIK surgery for high myopia and astigmatism
Topical steroid use versus no steroid use following LASIK surgery for enhancement of previous corneal surgery
Argon fluoride excimer laser for corneal surgery
OCUGEL viscoelastic surgical aid clinical investigation
Diclofenac sodium ophthalmic solution in the treatment of ocular pain after radial keratotomy
3M Fluropolymer Extended Wear
Evaluation of the safety and efficacy of unpreserved Diclofenac Sodium 0.1% ophthalmic solution for the reduction of postoperative ocular pain associated with excimer laser Photorefractive Keratectomy
A multi-center study to evaluate the safety and effectiveness of the clinical performance of the AMO PhacoFlex II insertion system